Fiber Laser Treatment System
FDA 510(k) K221770 · Shanghai Apolo Medical Technology Co., Ltd.
Submission
- Device name
- Fiber Laser Treatment System
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd.
Shanghai, CN - Received
- June 21, 2022
- Decision date
- October 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for…
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| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233)ONG · Traditional | 07/02/2025SE |
| K232409 | Electromagnetic Stimulation SystemsNGX · Traditional | 04/10/2024SE |
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| K200116 | PicoSecond Nd: YAG Laser SystemGEX · Traditional | 05/28/2020SE |
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Questions and answers
When was Fiber Laser Treatment System cleared by the FDA?
Fiber Laser Treatment System (K221770) received a 510(k) decision of Substantially Equivalent on October 13, 2022, 114 days after the submission was received.
What is the product code of K221770?
The FDA product code is ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output, a Class II (moderate risk) device regulated under 21 CFR 878.4810.